Immunotherapy (IT) is recognized as one of the most curative treatment for allergies. By exposing the immune system to slowly increasing concentrations of immunomodulators such as an allergen or antigen, it will eventually stabilize and regain control the portion that is hypersensitive to the allergen or antigen. In general, immunotherapy is the “treatment of disease by inducing, enhancing, or suppressing an immune response.” Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies, while immunotherapies that reduce or suppress are classified as suppression immunotherapies. The active agents of immunotherapy are collectively called immunomodulators. They are a diverse array of recombinant, synthetic and natural preparations, often cytokines.
Immunotherapy involved in the treatment of allergies is a type of suppression immunotherapy, often termed desensitization or hypo-sensitization. This is compared with allergy treatments such as antihistamines or corticosteroids which treat only the symptoms of allergic disease. Immunotherapy is the only available treatment that can modify the natural course of the allergies, by reducing sensitivity to the immunomodulators such as antigens or allergens. An antigen and an allergen can both cause one's immune system to respond. An allergen is an antigen, but not all antigens are allergens. An antigen is any substance that is capable of causing one's immune system to produce antibodies. They are typically organic, or living, produced proteins. An allergen is any antigen that causes an allergic reaction. A non-allergen antigen could be a bacteria, virus, parasite, or fungus that causes an infection. This could also be something else that causes antibody immune system response, like toxins, chemicals, tissue cells involved in transplants or blood cells from a blood transfusion. An allergen is an environmentally produced substance that causes an allergic reaction, although the substance may not be harmful. Allergens cause no reactions in some individuals, while possibly causing a hypersensitive reaction in others. Common allergens include such things as pollen, plants, smoke, feathers, perfumes, dust mites, toxic mold, food, drugs, animal dander, and insect bites and stings.
The exact mechanisms of how IT works are not fully understood, but they involve shifting a patient's immune response from a predominantly “allergic” T-lymphocyte response to a “non-allergic” T-lymphocyte response.
Current accepted processes for performing allergy immunotherapy include injecting immunomodulator matter in the form of antigen material into patient subjects. This is referred to as subcutaneous immunotherapy (SCIT), requiring a patient to visit a doctor's office for weekly injections. It is very expensive and time-consuming. A second technique, sublingual immunotherapy (SLIT), involves the application of allergy extracts (antigens), and allergens placed into a pill form and swallowed by the patient or disposed in “allergy drops” which are placed under the tongue for the allergens/antigens to be absorbed into the oral mucosa. Transdermal patches may have been used without much success and mostly were used for patch testing to see if a patient reacts to various chemicals or allergens.
Of the people who start traditional subcutaneous injected immunotherapy (SCIT), 90% fail to complete their therapy due to needle fatigue and not being able to see a doctor in their office once or more per week for several years. Further, doctors charge for every one of those visits. Further, doctors trained to give injections for allergies are concentrated in high population and upper middle class places. People in rural areas and people who do not live in upper middle class areas cannot get to an allergist for shots. Consider an inner city kid having to ride public transportation and pay a high copay just to get a high risk injection if an alternative therapy were available!
Allergies are also linked to depression and suicide and are among the top ten reasons for missed work and lost productivity. Lastly, allergies and asthma result in billions of dollars in lost productivity and healthcare costs among the 90% of allergy patients that either never get immunotherapy or fail immunotherapy delivered under its current administration methods.
Skin allergy testing is a method for medical diagnosis of allergies that attempts to provoke a small, controlled, allergic response. A microscopic amount of allergen is introduced to a patient's skin by various means. One of these is a prick test wherein an allergen is introduced by pricking the skin with a needle to introduce a small amount of allergen into the epithelial layer of the skin. Similar tests include the scratch test that involves a deep dermic scratch made with the blunt bottom of a lancet, an intra-dermic test involving a tiny quantity of allergen injected under the dermis with a hypodermic syringe, a scrap test involving a superficial scrape performed with the help of the bevel of a needle to remove the superficial layer of the epidermis and a patch test wherein a patch is applied to the skin, the patch containing a small amount of allergen.
In the prick test, a small amount of purified allergen is generally pricked onto the skin surface, usually the forearm. This test is usually done in order to identify allergies caused by such things as pet dander, dust, pollen, foods or dust mites. The skin prick test involves first placing a small amount of substances that may be causing the symptoms on the skin, most often on the forearm or upper arm back. Some of the prick test kits that are available are utilized to maximize the number of tests that can be performed with a given amount of allergen. Thus, a 5 mL bottle of allergen can provide up to 1800 tests. Typically, a number of wells formed in a tray are each filled with an allergen, for example with about 0.125 mL of extract. The tip of a pick or lancet is dipped into the small amount of extract disposed in the bottom of the well and then a particular site is pricked on an individual. In some cases multiple pricks are mounted in or on a frame to provide for multiple well associations, such that a series of six or seven wells in a line in the tray can be simultaneously accessed so that a number of different allergens can be applied to an individual's skin simultaneously. There are even larger arrays of picks that can be dipped into the wells for treating a large area with more different allergens at the same time. After use, the wells are typically sealed by inserting a prick into the well.
One of the issues involved in prick testing is that the allergen must be removed from a sterile bottle with a syringe to fill each well. The sterile bottle containing the allergen typically has some type of injection stopper, typically rubber, through which the hypodermic needle is inserted to extract the allergen. Once the hypodermic needle is inserted through the injection stopper, the sterile barrier is broken. The allergen is disposed into the well and the pick disposed therein multiple times. There is not necessarily any sterilization procedure between applying the allergen to the skin of an individual and then disposing the pick back into the well to seal that well. Thus, once the allergen is extracted from the 5 mL bottle, the first use of the allergen is the only sterile use. Thereafter, application thereof of the allergen up to 1800 times can potentially result in issues.